NCT03853200

Comparison of Antibacterial Efficacy of Three Final Irrigants

In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study was conducted to determine the antibacterial affect of three different solutions used as final irrigant during endodontic therapy. The investigator's objective was to compare the antibacterial affect of relatively new final irrigant QMix with EDTA and Qmix with EDTA+CHX by evaluating the bacteriological status of the root canal before and after use of the final irrigant.

Detailed description

The aim of this clinical trial is to compare the antibacterial efficacy of Qmix, to 17% EDTA+ Chlorhexidine and 17% EDTA, used as final irrigants, during endodontic procedure. Endodontic treatment was carried out on 90 necrosed teeth of patients under rubber dam isolation and strict sterilization protocol. The teeth were divided into three groups; A, B and C depending on the type of final irrigant to be used. The chemo-mechanical preparation of all the 90 samples was carried out using ProTaper Universal (Dentsply) File system, and 3% sodium Hypochlorite. All the samples from each group were then irrigated according to the final rinse protocol (FRP). Group A was irrigated with Qmix; Group B with 17% EDTA + 2% Chlorhexidine and Group C (Control group) 17% EDTA. Three bacteriologic samples were taken during the procedure from each root canal under study in all three groups, using sterile paper points. Sample A was collected after access cavity opening and negotiation of the canal but before chemo-mechanical preparation. Sample B was taken after chemo-mechanical preparation but before the use of the final irrigant. Sample C was collected after the use of final irrigation solution. The samples were collected with sterile paper points and were then transferred to microbiology laboratory in microtubes containing Brain Heart Infusion (BHI) broth within 2 hours of sample collection for obtaining the colony forming unit (CFU) counts.

Conditions

• Endodontic Disease
• Root Canal Infection

Interventions

Type	Name	Description
DRUG	QMix Root Canal Irrigant	Endodontic irrigant recommended for final irrigation
DRUG	17%EDTA+2%Chlorhexidine	two endodontic irrigants will be used in this group in a sequential manner
OTHER	EDTA	17% EDTA irrigation solution

Timeline

• Start date: 2017-04-03
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2019-02-25
• Last updated: 2019-02-25

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study